Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No funding available for the activity
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to compare the physiologic resolution of dental infections between immediate tooth extraction (control group) and administration of systemic antibiotics and delayed extraction (study groups 1 and 2). A secondary objective is two compare two different antibiotic regimens in the delayed extraction groups (study group 1 and 2).
This is a prospective partially randomized clinical trial. Patients 2-11 years old who have a vestibular swelling associated with an odontogenic infection are being studied. Subjects will self-select into the control or study group. All subjects will be offered to have the tooth extracted on the day of diagnosis, and if this treatment is chosen they will join the control group (group 1). Subjects who defer treatment will be placed on amoxicillin and will be placed into the study group. The study group will be randomized into two parallel study groups that either have average dose antibiotics for 10 days (group 2), or maximum dose antibiotics for 5 days (group 3).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extraction Only | Active Comparator | Immediate extraction of infected tooth without antibiotic prescription. |
|
| Average Dose Antibiotic | Experimental | Average dose antibiotic therapy(25 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 10 days and receive tooth extraction on day 10 (25 patients). (*given the average weight of a 12 year old is 45 kilos, we do not expect that we will reach the maximum dose in this group) |
|
| High Dose Antibiotic | Experimental | High dose antibiotic therapy (45 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 5 days and receive tooth extraction on day 10 (25 patients) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin | Drug | Antibiotic given at different dosages and durations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in diagnosis | Tooth infection not clinically detectable | Infection will be monitored at days 0, 5, 10 and 20. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of pediatric oral health-related quality of life: the POQL | Quality of life compared between arms. Pediatric Oral Health Quality of Life (PQOL) clustered into four dimensions - Physical Functioning, Role Functioning, Social Functioning and Emotional Functioning. It was designed to be used in high risk, low resource, populations with greater health disparities. Specifically we are looking significant difference between the study groups that is at least 2 standard errors from the control group. If there are not two deviations to discriminate between scales would indicate a non-significant finding. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keri Discepolo, DDS | Boston Children's Hospital | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2926541 | Background | Dodson TB, Perrott DH, Kaban LB. Pediatric maxillofacial infections: a retrospective study of 113 patients. J Oral Maxillofac Surg. 1989 Apr;47(4):327-30. doi: 10.1016/0278-2391(89)90331-5. | |
| 8089789 | Background | Biederman GR, Dodson TB. Epidemiologic review of facial infections in hospitalized pediatric patients. J Oral Maxillofac Surg. 1994 Oct;52(10):1042-5. doi: 10.1016/0278-2391(94)90172-4. |
Not provided
Not provided
There is no plan to share participant data.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005491 | Focal Infection, Dental |
| ID | Term |
|---|---|
| D005490 | Focal Infection |
| D007239 | Infections |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D014081 | Tooth Extraction |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
Not provided
Not provided
Prospective partially randomized parallel study groups clinical trial investigation.
Not provided
Not provided
Not provided
Not provided
| Tooth extraction | Procedure | Removal of infected tooth on first day of study, this approach does not require an antibiotic drug. |
|
|
| Survey of quality of life at days 0, 5, 10 and 20. |
| 17325089 | Background | Rush DE, Abdel-Haq N, Zhu JF, Aamar B, Malian M. Clindamycin versus Unasyn in the treatment of facial cellulitis of odontogenic origin in children. Clin Pediatr (Phila). 2007 Mar;46(2):154-9. doi: 10.1177/0009922806289431. |
| 18760616 | Background | Warnke PH, Becker ST, Springer IN, Haerle F, Ullmann U, Russo PA, Wiltfang J, Fickenscher H, Schubert S. Penicillin compared with other advanced broad spectrum antibiotics regarding antibacterial activity against oral pathogens isolated from odontogenic abscesses. J Craniomaxillofac Surg. 2008 Dec;36(8):462-7. doi: 10.1016/j.jcms.2008.07.001. Epub 2008 Aug 29. |
| 24717702 | Background | Kara A, Ozsurekci Y, Tekcicek M, Karadag Oncel E, Cengiz AB, Karahan S, Ceyhan M, Celik MO, Ozkaya-Parlakay A. Length of hospital stay and management of facial cellulitis of odontogenic origin in children. Pediatr Dent. 2014 Jan-Feb;36(1):18E-22E. |
| 16567986 | Background | Lin YT, Lu PW. Retrospective study of pediatric facial cellulitis of odontogenic origin. Pediatr Infect Dis J. 2006 Apr;25(4):339-42. doi: 10.1097/01.inf.0000216202.59529.3d. |
| 21972458 | Background | Huntington NL, Spetter D, Jones JA, Rich SE, Garcia RI, Spiro A 3rd. Development and validation of a measure of pediatric oral health-related quality of life: the POQL. J Public Health Dent. 2011 Summer;71(3):185-93. |
| 20637381 | Background | Thikkurissy S, Rawlins JT, Kumar A, Evans E, Casamassimo PS. Rapid treatment reduces hospitalization for pediatric patients with odontogenic-based cellulitis. Am J Emerg Med. 2010 Jul;28(6):668-72. doi: 10.1016/j.ajem.2009.02.028. Epub 2010 Apr 2. |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |